AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for:
Recalled November 6, 2019 · FDA recall D-0165-2020 · AVKARE
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
1351 bottles
Sold at
CO, MO
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →